MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715KL |
Device Problems
Device Alarm System (1012); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Power Problem (3010); Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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Information received by medtronic indicated that the insulin pump had failed battery alarm.Customer reported that the button stuck down when pressed.There was small scratches on screen and no effect on effect on readability.Customer reported insulin pump did not giving proper warning to low reservoir.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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After battery installation, device gave an unexpected blank/white flashing display followed by an unexpected intermittent beep alarm due to cracked lcd controller.Unable to perform displacement, rewind, prime/seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement and self tests or verify rewind, no delivery alarm/occlusion, low reservoir, keypad unresponsive/button error alarm and failed battery test due to display anomaly.P-cap / reservoir locks properly into place.Device received with scratched lcd window and cracked keypad overlay.(b)(4).
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Manufacturer Narrative
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This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0683-2019.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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